Events

Rappel de Device Recall ACCESS Ostase

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Beckman Coulter Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    61145
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1195-2012
  • Date de mise en oeuvre de l'événement
    2011-06-22
  • Date de publication de l'événement
    2012-03-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107395
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Electrophoretic separation, alkaline phosphatase isoenzymes - Product Code CIN
  • Cause
    The access ostase reagent lot 021281 shows instability resulting in falsely high patient results.
  • Action
    A recall communication was initiated on 6/15/2011 with Beckman forwarding an "Urgent Product Correction" (PCA) letter to all their customers who purchased the Access Immunoassay Systems Ostase Reagent Kits. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the Access Ostase reagent lot identified on the PCA letter and discard all remaining inventory. As stated in the Instructions for Use for Access Ostase, results should be interpreted in light of the total clinical presentation of the patient. All results generated with reagent lot number 021281 where patient results are higher than expected should be evaluated. The affected lot has been removed from Beckman's inventory, and alternate lots will be provided for all current and future replenishment orders or requests. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions can contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call(800) 854-3633 in the US and Canada.

Device

Device Recall ACCESS Ostase
  • Modèle / numéro de série
    Lot Number: 021281
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including states of FL, IN, VA, CA, and KY and countries of China, Japan, and Panama.
  • Description du dispositif
    ACCESS Ostase || Part Number: 37300 || Used for the quantitative measurement of bone alkaline phosphatase (BAP).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA